Development of a Policy and an Implementation Plan for Enhancement of
the Inclusion of Children in Sponsored Research:
Request for Comments
As was announced in the NIH GUIDE, Volume 26, Number 3,January 31, 1997, the National Institutes of Health (NIH) has embarked
on a thoughtful deliberation to develop a policy and an implementation
plan for requiring applicants proposing clinical research that addresses
conditions or disorders that affect adults and may also affect
children, to describe their plans for including or justifications for
excluding children in the research. The NIH and the American Aca
of Pediatrics held a joint workshop in June 1996 concerning the
participation of children in clinical research. There is valid
concern that treatment modalities developed based on research
conducted on adults, without adequate data from children, are being
used to treat children for many diseases/disorders. One of the
outcomes of the workshop was the recommendation that the NIH develop
a policy for including children in clinical research.
The NIH concluded that when there is a sound scientific rationale for
including children in research, investigators should be expected to
do so unless there is a strong overriding reason that justifies their
exclusion from the studies. Although this is the same scientific
rationale that is the basis for the policy requiring the inclusion of
women and minorities in clinical research, this policy does not
mandate the inclusion of children in all clinical research. Because
the issues and sensitivities surrounding children~s participation in
research are significantly different from those regarding women and
minorities, such a mandate would be inappropriate. Nonetheless, even
though the inclusion of children is not an absolute requirement,
applicants for NIH funding will be expected to address this issue in
their proposals.
The NIH recognizes that the development and implementation of this
policy will require the education and preparation of the scientific
community, parents, Institutional Review Boards, Initial Review
Groups, Advisory Councils, and NIH program staff. The purpose of
this notice is to provide information about ongoing efforts towards
the new policy--ample advance notice will be provided prior to the
formal implementation of the policy--and to REQUEST COMMENTS
FROM ALL INTERESTED PARTIES. In the meantime, investigators
are encouraged to consider including children in clinical research projects.
PLEASE EMAIL COMMENTS OR SUGGESTIONS TO:
Peter S. Jensen, M.D.
Chair, Outreach Subcommittee
Committee on Inclusion on Children in Research
Email Address: pjensen@nih.gov
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